News Category: Regulatory news
Regulation 2019/6, known as the New Veterinary Regulation, legislates for the authorisation, use and monitoring of veterinary medicinal products in the European Union. The legislation came into effect on 28 January 2019 and will apply in all EU Member States on 28 January 2022.
We have added a new Frequently Asked Questions page to the New Veterinary Regulation section of our website (hpra.ie/NewVetReg) to provide information about the practical implications of the new Regulation. The information aims to help industry stakeholders prepare for the forthcoming changes and includes responses to questions on pharmacovigilance, the Union Product Database, marketing authorisations and variations.
The information will be updated on an ongoing basis. If you would like to propose new questions to be addressed on this page, please email newvetreg@hpra.ie.